Trocars and veress-type needles with illuminated guidance and safety features

ABSTRACT

The present disclosure provides devices and methods for insufflating abdomens of subjects under direct visualization. Such devices and methods, in some implementations, include features for cleaning the devices, and certain implementations of the methods permit procedures wherein it is not necessary to use a typical obturator to place a cannula, resulting in safer procedures.

CROSS-REFERENCE TO RELATED APPLICATION

This patent application is a continuation of and claims the benefit ofpriority to U.S. patent application Ser. No. 17/501,232, filed Oct. 14,2021, which in turn is a continuation-in-part of and claims the benefitof priority to U.S. patent application Ser. No. 17/368,296, filed Jul.6, 2021, which in turn is a continuation-in-part of and claims thebenefit of priority to U.S. patent application Ser. No. 16/780,938,filed Feb. 4, 2020, now U.S. Pat. No. 11,051,851, which in turn is acontinuation-in-part of and claims the benefit of priority toInternational Patent Application No. PCT/US2018/45380, filed Aug. 6,2018, which in turn is related to and claims the benefit of priority toU.S. Provisional Patent Application No. 62/541,644, filed Aug. 4, 2017.The present patent application also claims the benefit of priority toU.S. Provisional Patent Application No. 63/139,298, filed Jan. 19, 2021.Each of the foregoing patent applications is hereby incorporated byreference in its entirety for any purpose whatsoever.

BACKGROUND Field

This disclosure relates to instruments and methods of use therefore inthe practice of laparoscopic surgery and more particularly to suchdevices that have utility in forming an incision and insufflating theunderlying body cavity in a safer manner than prior art devices.

Description of Related Art

In the practice of minimally invasive laparoscopic surgery it is commonto make a small incision through the skin and underlying tissue of thepatient, or subject, adjacent the internal surgical site using a Veressneedle. These needles include a tubular outer cannula with a sharpeneddistal end and an inner hollow cylindrical needle, or cannula, whichterminates in a blunt end. A spring assembly urges the inner cannulaforward so that the blunt end of the inner cannula extends beyond thecutting edge of the outer cannula. When the instrument is pressedagainst the skin of the patient the inner blunt cannula retracts therebypermitting the outer sharp cannula to contact the skin and advance intothe tissue. As soon as a body cavity is entered, the inner blunt cannulasprings forward, so that the accidental cutting of underlying organs bythe sharpened outer cannula is avoided.

The Veress needle typically includes means for introducing pressurizedgas, usually CO₂, into the proximal end of the needle so that the gas ispassed on through the laparoscopic incision and inflates the body cavityto allow easy access to the surgical site. After formation of a firstincision and insufflation of the body cavity, the Veress needle istypically removed and a trocar is placed through the same incision.

One problem associated with the use of such Veress needle assemblies isdetermining when the needle has progressed through the wall of the bodycavity and its distal end has emerged within the cavity. Additionally,inadvertent injury to internal organs such as bowel and major bloodvessels may occur during the insertion of a standard Veress needle. Thishappens because this initial entry is blind (i.e., the surgeon cannotsee where the needle is going). The present disclosure providessolutions to these and other problems in the art, as set forth below.

SUMMARY OF THE DISCLOSURE

Advantages of the present disclosure will be set forth in and becomeapparent from the description that follows. Additional advantages of thedisclosure will be realized and attained by the methods and systemsparticularly pointed out in the written description and claims hereof,as well as from the appended drawings.

In accordance with one aspect, the present disclosure is directed to anapparatus that includes a handle having proximal end and distal endconnected at the distal end to a hollow distally extending needle havinga distal end for penetrating tissue and a proximal end, wherein thehandle and hollow distally extending needle form a conduit for passingat least one of fluid or instruments therethrough. The apparatus furtherincludes a visualization stylet having a proximal end and a distal end,said visualization stylet being slidably disposed within the conduit,wherein a distal end region of the visualization stylet includes anelectronic photodetector chip mounted thereon having a distally facingsurface configured to detect incoming light traveling along a proximaldirection. The visualization stylet can further include a light sourceconfigured to project light beyond the electronic photodetector chip ina distal direction to provide direct illumination, wherein lightoriginating from the light source is reflected back to the electronicphotodetector chip when the apparatus is traveling through tissue. Theapparatus can further include a spring housed within the handle forbiasing the visualization stylet to extend past the sharp distal end ofthe hollow distally extending needle absent resistance by tissue againstthe visualization stylet.

In further implementations, the visualization stylet can include a lenselement disposed on a distal tip thereof over the electronicphotodetector chip. In some embodiments, the lens element can directlycontact the electronic photodetector chip. In some implementations, thelens element can be axially spaced with respect to the electronicphotodetector chip. If desired, the lens element can be controllably,adjustably axially spaced with respect to the electronic photodetectorchip to permit a user to focus incoming light passing through the lensonto the electronic photodetector chip. For example, axial spacing ofthe lens element from the electronic photodetector chip along a centrallongitudinal axis of the apparatus can be adjusted by sliding the lenselement with respect to the electronic photodetector chip.

If desired, axial spacing of the lens element from the electronicphotodetector chip along a central longitudinal axis of the apparatuscan be adjusted by rotating the lens element with respect to theelectronic photodetector chip. In some embodiments, the lens element caninclude a convex lens, a plano-convex lens, or other lens. The lenselement can be, for example, conically shaped, pyramid-shaped, or domeshaped, among others. In some implementations, the lens element caninclude a central lens configured to focus incoming light on theelectronic photodetector chip surrounded by a plurality of secondarylenses configured and arranged to disperse light transmitted distallyfrom the lens element originating from the light source.

In some embodiments, the light source can includes a bundle of fiberoptic elements coupled to a source of light. If desired, the lightsource can include at least one micro-LED element surrounding theelectronic photodetector chip. The at least one micro-LED element caninclude an optic disposed thereon that focuses and directs light fromthe at least one micro-LED element onto at least one of the secondarylenses. If desired, the lens element can include a central lensconfigured to focus incoming light on the electronic photodetector chipsurrounded by an annular region of the lens, wherein the central lens isradially separated from the annular region of the lens by at least onefluid flow channel configured and arranged to direct a jet of cleaningfluid over at least a portion of the central lens. In someimplementations, the central lens and the annular region of the lens canbe integrally molded. If desired, the central lens and the annularregion of the lens can be formed from at least two discrete components.

In some implementations, the apparatus can further include at least onefluid flow channel configured and arranged to direct a jet of cleaningfluid over at least a portion of a central lens disposed at the distalend of the visualization stylet. The at least one fluid flow channel canbe defined by at least one tubular member slidably disposed along thevisualization stylet, the tubular member(s) defining a plurality ofspray openings in a side wall thereof If desired, the tubular member(s)can be formed from a shape memory material. A distal region of thetubular member(s) can be advanced distally out from the visualizationstylet, and takes on a heat set curvature that causes the tubular memberto bend toward the lens element.

In some embodiments, if correspondingly equipped, the axial spacing ofthe lens element from the electronic photodetector chip can be adjustedby actuating an actuator near a proximal end of the visualizationstylet. If desired, any of the lens elements disclosed herein caninclude at least one vent hole therein, for example, for passage ofinsufflation gas, and/or to facilitate the focusing of the lens elementby permitting axial repositioning of the lens with respect to the restof the visualization stylet.

In some embodiments, the at least one fluid flow channel can be definedby at least one tubular member attached to an inner wall of the conduitof the hollow needle. The tubular member can define a plurality of sprayopenings in a side wall thereof configured and arranged to clean thelens by directing a transverse flow of fluid across the lens. Thevisualization stylet can also define at least one elongate insufflationconduit therein configured to pass insufflation gas therethrough to adistal end region of the apparatus. Insufflation gas can exit through atleast one opening defined through a sidewall of the visualization styletnear a distal tip of the visualization stylet. The visualization styletcan be formed at least in part from a light transmitting material. Thelight source can include at least one LED disposed in the proximal endof the handle, for example.

In some implementations, the apparatus can further include a gasintroduction port for receiving insufflation gas from a gas source. Thevisualization stylet can be configured to be withdrawn proximally toestablish a flow path for insufflation gas to pass through theapparatus. The visualization stylet can further include a conductor fordirecting signals received from the electronic photodetector chip to aprocessor. The processor can be attached to the visualization stylet. Ifdesired, the apparatus can further include a display screen fordisplaying images captured by the electronic photodetector chip. Ifdesired, the apparatus can further include a battery for powering theelectronic photodetector chip, processor and display screen.

The disclosure further provides a variety of methods for treatingsubject, such as a patient. For example, a first embodiment of a methodis provided of using devices such as those described herein. Some of themethods can include creating a small superficial incision in skin of anabdomen of a subject, advancing a distal end of a hollow distallyextending needle including a visualization stylet disposed thereinthrough successive layers of an abdominal wall of the subject whileviewing tissue being advanced through by way of the visualization styletin real time, the visualization stylet being configured to view in adistal direction, and stopping advancing the distal end of the hollowdistally extending needle upon observing the visualization styletextending distally with respect to the hollow distally extending needleindicating that an abdominal cavity of the subject has been reached.

In some implementations, the method can further include commencinginsufflation through the hollow distally extending needle after stoppingadvancing the distal end of the hollow distally extending needle.Commencing insufflation through the hollow distally extending needle canfurther include removing the visualization stylet through the proximalend of the hollow distally extending needle and injecting gas throughthe hollow distally extending needle. If desired, the method can furtherinclude comprising directing signals from the electronic photodetectorchip to a processor. The method can further include directing signalsfrom the processor to a display screen.

In some embodiments of the method, the hollow distally extending needlecan act as a sheath that at least partially covers the visualizationstylet along its length. The handle can include a cannula that isremovably attached to the hollow distally extending needle. The methodcan further include, after insufflation, removing the cannula from thehollow distally extending needle and withdrawing the cannula proximallyover the visualization stylet. Removing the cannula can includedisconnecting a threaded connection joining the hollow distallyextending needle and the cannula. If desired, the method can furtherinclude attaching a proximal extension to at least one of the hollowdistally extending needle and the visualization stylet to form anassembly, and performing a laparoscopic procedure using the assembly asan endoscope. If desired, the method can further include separating thehollow distally extending needle and handle from the visualizationstylet and removing one of the visualization stylet and hollow distallyextending needle and handle from the subject. Once the visualizationstylet is removed, the method can include leaving the hollow distallyextending needle in place to function as a cannula for performing afurther procedure.

The method, can further include, in some embodiments, removing a lenscap from the visualization stylet, and reintroducing the visualizationstylet into the handle and the hollow distally extending needle withoutthe lens cap. The lens cap can be removed, for example, by articulatingthe lens cap away from the distal end of the visualization stylet on ahinge.

Disclosed methods can also include, for example, directing a cleaningfluid including at least one of a liquid or gas at least partly in atransverse direction across the distal end of the visualization styletwhile inside the subject to enhance visualization. Directing a cleaningfluid can include distally extending a cleaning wand that is configuredand adapted to direct cleaning fluid toward the distal end of thevisualization stylet. Directing the cleaning fluid can include directingthe cleaning fluid through the visualization stylet and out through atleast one opening at the distal end region of the visualization stylet.Directing the cleaning fluid can include directing the cleaning fluidthrough a lens located at the distal end of the visualization stylet.The cleaning fluid can be directed at least partially along a radiallyinward path across a central region of the lens. Directing the cleaningfluid can include directing the cleaning fluid through the hollowdistally extending needle. If desired, directing the cleaning fluid caninclude directing the cleaning fluid through at least one tubularpassage disposed between the visualization stylet and an inner bore ofthe hollow distally extending needle, wherein the at least one tubularpassage is attached to the inner bore of the hollow distally extendingneedle.

In further accordance with the disclosure, the method can includeremoving the hollow distally extending needle and handle, leaving thevisualization stylet in place. If desired, the method can furtherinclude adding a proximal extension to the visualization stylet to forman assembly, and using the assembly as an endoscope. The method canfurther include disposing a cannula having a bore diameter at leasttwice the diameter of the visualization stylet over the visualizationstylet, causing the tissue to dilate radially outwardly. If desired, thevisualization stylet can have a diameter of 1 to 2 mm, for example, andthe cannula can have a 5mm bore. If desired, the visualization styletcan have a diameter of 1 to 2 mm, and the cannula can have a 10 mm bore.

If desired, the method can further include withdrawing the visualizationstylet, leaving the cannula in place. The method can further includeintroducing a further instrument through the cannula. The furtherinstrument can be an endoscope configured to match a size of a bore ofthe cannula.

In further accordance with the disclosure, implementations of a surgicalinstrument are provided. In some implementations, the surgicalinstrument includes a distal outer assembly including a distal housinghaving a fluid input port and a hollow distally extending needleextending distally therefrom. The hollow distally extending needle has adistal end and a proximal end, wherein the distal outer assembly forms apassageway to pass at least one of fluid and instruments therethrough.The surgical instrument further includes a visualization stylet assemblyat least partially disposed within the passageway of the distal outerassembly. The visualization stylet assembly is removably coupled to thedistal outer assembly. The visualization stylet includes an elongatebody having a proximal end and a distal end, an electronic photodetectorchip mounted proximate the distal end of the elongate body, theelectronic photodetector chip having a distally facing surface to detectincoming light traveling along a proximal direction, a light source atleast partially integrated into the elongate body to project lightbeyond the electronic photodetector chip in a distal direction toprovide direct illumination to guide passage of the insufflation needleassembly, and a sleeve slidably disposed about at least a distal tipregion of the removable visualization stylet assembly. The sleeve caninclude a lens element disposed at a distal end thereof to direct lightthrough the lens element toward the electronic photodetector chip. Atleast a portion of the sleeve can extend proximally through the hollowdistally extending needle. The sleeve can terminate in a proximal handleportion of the sleeve to facilitate relative movement of the sleeve tothe elongate body. The distal outer assembly and the removablevisualization stylet assembly can be removably coupled together with thesleeve to permit the outer assembly, removable visualization stylet, andsleeve to be advanced through tissue as a single structural unit.

In some implementations, the visualization stylet assembly can beconfigured to be removed from the distal outer assembly with the sleeve,and the sleeve can be removed from around the removable visualizationstylet assembly to expose the electronic photodetector chip and topermit the removable visualization stylet assembly to be reintroducedinto the conduit of the outer assembly without the sleeve thereon.

In some implementations, the surgical instrument can be an insufflationneedle assembly, or can be a trocar assembly. As an insufflation needleassembly, the removable visualization stylet assembly can include aproximal housing portion defining a bore therein that includes acompression spring disposed therein. The elongate body of thevisualization stylet assembly can be biased in a distal direction withrespect to the proximal housing portion by the compression spring tocause the sleeve and elongate body to extend beyond the distal end ofthe hollow distally extending needle. In some embodiments, thevisualization stylet assembly can further include a connector bodydisposed concentrically about a proximal region of the elongate body.The connector body can include a distally facing connector to removablycouple to the handle portion of the sleeve.

The visualization stylet assembly can further include a connector bodydisposed concentrically about a proximal region of the elongate body,and the connector body can include a distally facing connector toremovably couple to the handle portion of the sleeve, the connector bodybeing received at least partially within the proximal housing of thesurgical instrument. If desired, the handle of the sleeve can include afemale locking member that is received by a male locking member of theconnector body (or vice-versa) to permit the sleeve to be selectivelydecoupled from the visualization stylet assembly to expose theelectronic photodetector chip.

In some implementations, the proximal housing can define a distallyextending boss to be sealingly received by the distal outer assembly.The distally extending boss can be surrounded by a fluid tight seal tointerface with an inwardly facing surface of the distal outer assembly.The distal outer assembly can further include a guide tube, of a funnelshape, for example, disposed within the passageway of the distal outerbody to guide the visualization stylet assembly into the hollow distallyextending needle.

In some implementations, the visualization stylet assembly can furtherinclude a heat sink at least partially disposed within the proximalhousing to dissipate heat generated by the surgical instrument. Ifdesired, the proximal housing can define a proximal cavity in which theelongate body of the visualization terminates at the proximal end of theelongate body. At least one cable can extend from the proximal end ofthe elongate body through the proximal cavity, through the heat sink,and to a connector located within a proximal cap of the proximalhousing. If desired, the heat sink can include a proximal end, a distalend and define a bore at least partially therethrough. A LED chip can bemounted at least partially within the bore of the heat sink. The LEDchip can include a distally facing LED to direct light into thevisualization stylet to provide forward illumination.

In further accordance with the disclosure, implementations of aninsufflation needle assembly is provided that includes a distal assemblyincluding a hollow distally extending needle having a sharpened distalend, a proximal end, and defining a needle bore therethrough. The hollowdistally extending needle can be coupled at the proximal end thereof toa distal housing. The distal housing can define a proximal openingtherein leading to a cavity. The cavity can be in fluid communicationwith the needle bore. The insufflation needle assembly can furtherinclude a proximal assembly that includes a proximal housing, acompression spring disposed in a bore of the proximal housing, and avisualization stylet. The visualization stylet can include (i) anelongate body defining a proximal end and a distal end, (ii) anelectronic photodetector chip mounted proximate the distal end of theelongate body, the electronic photodetector chip having a distallyfacing surface to detect incoming light traveling along a proximaldirection, (iii) a light source at least partially integrated into theelongate body to project light beyond the electronic photodetector chipin a distal direction to provide direct illumination to guide passage ofthe insufflation needle assembly, and (iv) a boss in contact with adistal end of the compression spring to urge the visualization stylet ina distal direction, for example. The proximal assembly can be configuredto be received by the distal assembly and the proximal assembly can beconfigured to be removably coupled to the distal assembly. Thevisualization stylet can be biased to extend beyond the distal end ofthe hollow distally extending needle.

In some implementations, the proximal housing can form a handle of thedevice. The handle can be defined by a distal handle segment that isreceived by the distal housing. The distal handle segment can include aperipheral seal to interface with an inwardly facing surface of thedistal housing. The handle can further include a proximal handle segmentsealingly received by the distal handle segment, wherein the proximalhandle segment and distal handle segment cooperate to define a springbore to receive the compression spring. The boss of the visualizationstylet can be disposed within the spring bore at a location distalrelative to the compression spring. The compression spring surrounds alength of the elongate body of the visualization stylet located proximalto the boss. If desired, the spring can be removed from the handle byseparating the proximal handle segment from the distal handle segmentand withdrawing the elongate member from the distal handle segment whilethe elongate body is coupled to the proximal handle segment.

In some implementations, the proximal handle segment can define aproximally facing bore. The elongate body of the visualization styletcan terminate at a proximal end thereof within the proximally facingbore and be attached to a bushing that is sealingly received within theproximally facing bore of the proximal handle segment.

In some implementations, the proximal handle segment can be coupled at aproximal end thereof to a strain relief assembly. The strain reliefassembly can define a region of varying stiffness. The strain reliefassembly can terminate proximally in a plurality of connectors. Theconnectors can be coupled to conductors that traverse the elongate bodyof the visualization stylet. In some implementations, the conductors cantraverse distally from the connectors, through the strain reliefassembly, through the proximal cavity of the proximal handle segment,and into the elongate body of the visualization stylet. If desired, thestrain relief can include a distally extending boss that is receivedwithin a proximal end of the proximally facing bore of the proximalhandle segment. In some implementations, the distal assembly can becoupled to the proximal assembly in at least two discrete axiallydistinct positions.

It is to be understood that the foregoing general description and thefollowing detailed description are exemplary and are intended to providefurther explanation of the disclosed embodiments. The accompanyingdrawings, which are incorporated in and constitute part of thisspecification, are included to illustrate and provide a furtherunderstanding of the disclosed methods and systems. Together with thedescription, the drawings serve to explain principles of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects, advantages and applications of the present disclosurewill be made apparent by the following detailed description. Thedescription makes reference to the accompany drawings in which:

FIGS. 1A-FIG. 1B present various views of a first embodiment inaccordance with the present disclosure.

FIGS. 2A-FIG. 2C present various views of a second embodiment inaccordance with the present disclosure.

FIGS. 3-10 present various embodiments of visualization stylet distaltip and lens configurations in accordance with the present disclosure.

FIGS. 11A-FIG. 11B present various views of a further embodiment ofvisualization stylet distal tip and lens configuration in accordancewith the present disclosure.

FIGS. 12A-FIG. 12B present a cross sectional and side view, respectivelyof a further embodiment of visualization stylet distal tip and lensconfiguration in accordance with the present disclosure.

FIGS. 13A-FIG. 13B present a cross sectional and end view, respectivelyof a further embodiment of a device in accordance with the presentdisclosure that is configured to facilitate cleaning of a distal tip ofthe visualization stylet.

FIGS. 14A-FIG. 14C present views of steps of a method in accordance withthe present disclosure.

FIGS. 15A-FIG. 15C present views of steps of still a further method inaccordance with the present disclosure.

FIGS. 16A-FIG. 16C present views of steps of yet another method inaccordance with the present disclosure.

FIGS. 17A is an isometric view of an optical trocar assembly inaccordance with the present disclosure.

FIG. 17B is a close up view of a portion of the device depicted in FIG.17A.

FIGS. 17C-17E are views of a removable sheath of the device of FIG. 17A.

FIG. 18A is a view of the device of FIG. 17A prior to separatingcomponents to remove the sheath from the device.

FIG. 18B is a view of the device of FIG. 17A after rotating a handleportion of the device with respect to a cannula portion of the device.

FIG. 18C is a view of the device of FIG. 17A after withdrawing anassembly of the handle portion with the sheath attached thereto from thecannula portion of the device.

FIGS. 18D-18G illustrate a sequence of steps of rotating the sheath withrespect to the handle portion of the device and removing the sheathportion from the handle portion (FIG. 18G).

FIG. 18H is a view showing relative placement of the cannula, sheath andhandle after the sheath has been removed.

FIGS. 18I-18K illustrate reinserting the handle with the optical shaftinto the cannula after having removed the sheath.

FIG. 18 L is an isometric view of the handle of the device with theoptical probe, FIG. 18M shows a close up view of a distal end of theoptical probe and FIG. 18N illustrates a close up view of a distal endportion of the handle.

FIGS. 19A-19B illustrate full and partial isometric views of a springloaded insufflation needle assembly in accordance with the presentdisclosure.

FIGS. 19C and 19D show cross sectional views of the device of FIG. 19Aalong a central axis of the device rotated 90 degrees with respect toeach other.

FIGS. 19E-19H are views of an optical probe portion of the device ofFIG. 19A.

FIG. 20A is a view of a further embodiment of an insufflation needleassembly in accordance with the present disclosure.

FIGS. 20B-20E show further aspects of the embodiment of FIG. 20A.

FIGS. 20E-20I show still further aspects of the embodiment of FIG. 20A.

FIGS. 20J-20L depict schematic views of the embodiment of FIG. 20A.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

A preferred embodiment of the disclosure, illustrated in FIGS. 1A-1B,acts as a Veress needle to form an incision into a body cavity, as aninsufflator to inject gas into the cavity, and as a visualization toolto monitor progress of the Veress needle as it traverses through tissuewhile progressing toward the abdominal cavity.

Abdominal entry is the most dangerous step of laparoscopic and roboticsurgery and is responsible for one patient death—and 8 patientinjuries—in the US each day 4.8 million laparoscopic procedures per yearare performed in the US. Of these, the vascular injury risk 0.2/1000,the bowel injury risk 0.4/1000, and there is a mortality rate of 13%.There are 2,880 entry related injuries per year, and 374 deaths peryear; at least one death per day. Each of these injuries will costhundreds of thousands of dollars, sometimes millions of dollars, toaddress. The disclosed embodiments essentially eliminate blindlaparoscopic entry, preventing serious patient injuries and death.

For purposes of illustration, and not limitation, as embodied herein andas illustrated in FIG. 1, an apparatus 100 is provided in the form aVeress-type needle. The apparatus 100 includes a handle 110 havingproximal end 112 a distal end 114 and a hollow elongate passage 116therethrough that is in turn connected to a hollow distally extendingneedle 120 having a sharp distal end 124 for penetrating tissue and thatdefines a hollow elongate passage 126 therethrough. The passages 116,126 of the handle 110 and the needle 120 cooperate to form a conduit forpassing at least one of fluid or instruments therethrough.

The apparatus 100 further includes a visualization stylet 140 that inturn includes a proximal end 142 and a blunt distal end 144. Thevisualization stylet 140 is slidably disposed within the conduit (116,126) of the handle 110 and needle 120. As illustrated, a distal endregion of the visualization stylet 140 includes an electronicphotodetector chip 146 mounted thereon (or therein) having a distallyfacing surface 146 a including an array of photo sensors that areconfigured to detect incoming light traveling along a proximal direction(i.e., toward the distal end of the apparatus 100). The apparatus 100further includes a light source 150, such as a LED disposed in thehandle 110, configured to project light beyond the electronicphotodetector chip 146 in a distal direction to provide directillumination of an area being traversed by the apparatus 100. Inoperation, light originating from the light source 150 traverses thebody of the visualization stylet (which can be made from lighttransmissive plastic, for example) and illuminates the tissueimmediately distal to the visualization stylet 140. That light isreflected back to the electronic photodetector chip 146. In accordancewith further implementations, one or more fiber optic light transmittingfibers can be used to transmit light from a light source either insideor outside the handle 110 through the device to the distal end of thedevice. Light may be transmitted using fiber optic fibers down thevisualization stylet, and/or the needle 120 and handle 110.

The apparatus 100 still further includes a spring 160 housed within thehandle 100 for biasing the visualization stylet 140 (via boss(es)) 147to extend past the sharp distal end 124 of the needle 120 absentresistance by tissue against the visualization stylet. Thus, in use,while the apparatus is urged against tissue, the visualization styleturges against the tissue with the needle distal end 124. Once theapparatus traverses the abdominal wall, however, and enters theabdominal cavity, visualization stylet 140 is urged forward by spring160 beyond the needle distal end 124, thereby preventing the needle 120from cutting through any additional tissue in the abdominal cavity,including, for example, bowels, blood vessels, and the like.

If desired, the visualization stylet 140 can include a lens element 148disposed on a distal tip thereof over the electronic photodetector chip146. Preferably, the lens element can include a solid or hollow piece ofplastic, glass, or other suitable material that can be attached to theelectronic photodetector chip. In some implementations, the electronicphotodetector chip 146 can be integrally molded into a clear plasticbody of the visualization stylet 140, wherein a lens is molded over theelectronic photodetector chip and further wherein a conductor 148leading away from the electronic photodetector chip can be directed, forexample, along a central axis of the visualization stylet (or the deviceoverall) either embedded in the material of the visualization stylet(via an overmold), or by directing it through a hollow passage (notshown) along the central axis of the visualization stylet 140. Ifdesired, the molding process can result in clear plastic materialdirectly contacting the surface of the electronic photodetector chip.

The visualization stylet can thus be formed from a light transmissive(e.g., transparent or translucent) material such as PET or acrylic, orcan be made from other material with one or more fiber optics traversingthe length of the visualization stylet to transmit light from the lightsource. As illustrated, an annular outer area 144 a of the distal end144 of the visualization stylet 140 proximal to the electronicphotodetector chip 146 can be provided wherein the electronicphotodetector chip is in the middle of the distal end 144 to permitlight to be conducted down the visualization stylet, past the electronicphotodetector chip 146, and through the lens 148.

As further illustrated, the handle 110 can be provided with a gasintroduction port 118 for receiving insufflation gas from a gas source170. Also, if desired, a flush port 119 can be provided that can directa liquid in the annular space defined between the handle 110/needle 120and the visualization stylet 140 to clean the distal end of thevisualization stylet. Additionally or alternatively, a flush port can beprovided as a parallel lumen structure, indicated by 119 a. In someimplementations, the visualization stylet 140 is configured to bewithdrawn proximally along passages 126, 116 to establish a flow pathfor the insufflation gas. For example, the visualization stylet needonly be withdrawn proximal to the gas introduction port to provide aclear path for directing insufflation gas into the abdominal cavity of asubject.

As mentioned above, the conductor 148 can be provided for directingsignals received from the electronic photodetector chip to a secondlocation, such as a processor 180. The processor can thus be coupled tothe visualization stylet. The processor can then, in turn, be connectedto a display screen 190 for displaying images captured by the electronicphotodetector chip 146. The display device 190 can be a large LCD screenthat is a part of a separate computer system, or it may be provided as asmall local screen attached to the processor and a battery 192 in amodule attached to a proximal end 102 of the apparatus, for example. Ifdesired, an adapter (not shown) can be provided to connect the apparatus100 to a laparoscopic camera, light source and monitor that is availablein the operating room.

The disclosure further provides a method of using an apparatus asdescribed herein to more safely accomplish an insufflation procedure inpreparation for a laparoscopic surgical procedure in the abdomen. Themethod includes puncturing a surface of skin of a subject with a sharpdistal end of a hollow needle (e.g., 124) of the apparatus (e.g., 100).The method further includes advancing the distal end of the hollowneedle (e.g., 124) through successive layers of the abdominal wall ofthe subject while viewing the tissue being advanced through via thevisualization stylet in real time. The process still further includesstopping advancement of the distal end of the hollow needle whenreaching the abdominal cavity. A user can note that the abdominal cavityhas been reached when the visualization stylet shoots distally underforce of the spring 160 past the distal end 124 of the needle 120. Atthis point, the visualization stylet 140 can be retracted proximally,such as under manual action, and the method can further includecommencing insufflation through the hollow needle.

In further accordance with the disclosure, a second embodiment of avisualization insufflation needle assembly 200 is presented in FIGS.2A-2C. With reference to FIG. 2A, the assembly includes an outer sheath220 with an angled, sharpened distal tip for penetrating tissue,including a spring loaded visualization stylet, similar to that in FIGS.1A-1B. The outer sheath can be made, for example, from stainless steeltubing, and have a length L1 between for example, about 2 and about 6inches, in increments of about one eighth of an inch. Visualizationstylet can have a similar length L2. The diameter, or width, W2, of thevisualization stylet can be, for example, between about 0.050 to about0.1 inches in increments of 0.01 inches. The sheath can have a diameteror width W1 between about 0.06 and 0.12 inches, in increments of 0.01inches. The distal tube 220 is attached at a proximal end to a cannulabody 230 with a cannula cap 232 that may be removable. A spring biasingmechanism similar in functionality to that illustrated in FIG. 1A iscontained within cannula body 230 that is operably attached to thevisualization stylet for biasing it beyond the tip of the outer tube220. Cannula 230 can have a length L3 between, for example, about 1.5and 2.0 inches, in increments of one sixteenth of an inch, and a widthor diameter W3 between about 0.4 and 0.8 inches, in increments of about0.05 inches. The proximal end of cap 232 is adjacent to a female Luerlock connector 234 with a Y connector 242 and proximal male Luer lockconnector 240. Connector 240 is received by an electronics connector 250having a proximal plug 252 that in turn connects to a light source 266for directing light down the visualization stylet to provideillumination and to a camera output connector 264 for directing digitalimage data to a processor and/or screen. If desired, connector 264 caninclude specialized circuitry specifically configured for convertingdata received from the photodetector in the visualization stylet into avideo output signal. Sheathing 262 is provided for protecting the videooutput cable. Body 250 can have any suitable length L, for example,between about 0.75 and 2.0 inches in increments of 0.1 inches and adiameter or width W4 between about 0.4 and 0.8 inches, in increments ofabout 0.05 inches. Length L5 can be between, for example, 8 and 24inches or in any increment therebetween of about one quarter inch.

FIGS. 2B and 2C present end and cross sectional views of the distal endregion of the visualization stylet. FIG. 2B shows a view of the distalend with the lens 248 removed, thereby illustrating the photodetectorarray 246 and surrounding structures. Light is transmitted distallythrough illumination bundle 249 which surrounds the photodetector array246. Illumination bundle is in turn surrounded by a polymericillumination sheath 243, made for example of a suitable polymer such aspolyimide. A transverse opening 247 is provided for permittinginsufflation gas passing down the hollow bore of the visualizationstylet to pass through the outer wall of the visualization stylet forinsufflation of the peritoneum. Conductors (not shown) are connected toarray 246 to conduct data indicative of light received by the arrayproximally and out of device 200. Sheath 243 is in turn surrounded by a(preferably metallic) tubular member 245 that is attached at itsproximal end to a spring that is also attached to cannula body 250.

The visualization stylet, particularly the distal end region of thevisualization stylet, can be made in a variety of ways and having avariety of features. FIGS. 3-11A illustrate cross sectional views ofdifferent embodiments of this portion of the device (e.g., 100, 200)that include like reference numbers for similar structures.

FIG. 3 illustrates such a distal region having a distal lens cap 348that is substantially conically shaped with a curved tip that can beuseful for blunt dissection. The cap is defined by a solid or hollow endregion that can be a conic section, for example, that transitions intoan annular tubular region that is slidably received, for example (andadhered or otherwise attached to) a recessed portion 345 of a main bodyportion of the visualization stylet, which in turn includes aphotodetector array 346 (shown in simplified form). Illumination bundlesand other structures similar to the embodiment of FIGS. 2B-2C can alsobe provided. One or more central passages 347 can also be provided toaccommodate the passage of data conductors or the passage of liquid orgaseous flushing fluids for irrigating the tip of lens 348, as desired.FIG. 4 illustrates a distal end region that alternatively includes asharp conical, or pyramid (e.g., 3, 4, 5, or 6 sided) shaped lens 448.

FIG. 5 is similar to the embodiments of FIGS. 3 and 4, but includes adome shaped lens 548, and photodetector 546 and the like. Additionally,the embodiment of FIG. 5 includes a first embodiment of a lens flushingmechanism that includes a tubular body 547 directed through the body ofthe visualization stylet that includes a plurality of flushing holes.The body 547 can be formed from a hypotube, for example, with a sealeddistal tip and one or more transversely formed holes through thehypotube to direct a fluid jet across the lens, wherein the fluid caninclude, for example, saline, another liquid and/or a gaseous substance,such as carbon dioxide insufflation gas. Tube 547 is preferably slidablymovable with respect to visualization stylet, and can be controllablydeployed by advancing it distally with respect to the visualizationstylet distal tip. In one embodiment, the tube 547 is made from a shapememory material (e.g., Ni Ti alloy) wherein it is heat set to bendaround the tip to direct cleaning liquid and/or gas at the tip along adirection that is partially transverse and partially axial in a proximaldirection. The tube 547 can still be retracted proximally into astraight guide channel. If desired, more than one such tube 547 (Ni Tior other material) can be provided at various locations to effectuateefficient cleaning. In further embodiments of devices and methods (notillustrated), a mechanical wiping seal or wiping pad is provided insidethe cannula or sheath for wiping off the distal tip of the visualizationstylet.

FIG. 6 illustrates an embodiment similar to that of FIG. 5, wherein thata cavity 652 is provided between the distal tip of the photodetectorarray and the distal lens 648. If desired, a flush channel 654 can beprovided for directing liquid and/or gas into cavity 652 for enhancingoptical performance. In such an instance, a small vent hole can beprovided. Moreover, if desired, one or more circumferentially locatedflush channels 650 can be provided that pass through the lens 648. Ifdesired, in some embodiments, such flush channels can be distributedacross the surface of the tip to help keep it clean. Preferably theindex of refraction of the flushing fluid, e.g., a liquid, is matched tothat of the material of the tip to minimize image distortion.Furthermore, if desired, the tip of the central region of the lens canbe located proximally with respect to the circumference of the lens.This permits, as shown, flush passages that vector flushing fluid(liquid and/or gas) over the face of the central portion of the lens648. Moreover, it will be appreciated that the flush passages do notnecessarily need to be directed radially inward, or at least notsignificantly, in order to obtain a cleaning benefit. Specifically,Applicant believes that suitably configured cleaning passages andsuitable flow rates for liquids (e.g., saline) and/or gases (e.g.,carbon dioxide) will result in cleaning fluid streams that hug thesurface of the lens, even as it curves toward the distal tip. This isknown in fluid mechanics as the “Coandă effect”. Specifically, theCoandă effect is the phenomena in which a jet flow attaches itself to anearby surface and remains attached even when the surface curves awayfrom the initial jet direction. Thus, it is possible to have thebenefits of cleaning passages while minimizing their effect on reductionof field of view of the lens, and/or image distortion through the lens.Thus, for example, a liquid stream can be ejected through the cleaningpassages and followed by a burst of gas flow. Alternatively, simply agas flow can be used through the passages.

If desired, the distal tip can be formed by fitting a separate lens 650into the circumferential region. This can be done, for example, byattaching the lens center 650 to the photodetector 646 or to the lighttransmitting bundles surrounding it, by extending the proximal face ofthe lens central region so that it abuts the photodetector and/orsurrounding area. In that instance, the annular outer portion of thelens can be provided in the form of a separate tubular member that slipsover the center region of the lens. If desired, in that instance, thelens center 650 and/or the peripheral region can be provided withstandoffs, preferably that are circumferentially disposed (preferablythree, but other amounts can be used), to separate and align the innercentral portion of the lens 650 with the annular outer portion, and alsoto define the flow path for the flush channels.

FIG. 7 illustrates a further embodiment wherein the lens 748 is slidablymounted on the visualization stylet to permit adjusting the axialdistance between the lens and the photodetector 748 to accommodate forfocal length of the lens. This can be accomplished by an interferencefit that is adjustable, or by way of a push pull actuation arrangementdiscussed below with respect to FIGS. 12A-12B. FIG. 8 shows analternative focal length adjustment arrangement that utilizes a screwthread connection between the lens 848 and the body of the visualizationstylet to adjust the axial distance between the lens and photodetector846. FIG. 9 illustrates a ray diagram showing the lens 948 in the formof a plano-convex lens that is configured to focus incoming lightradially inwardly on the photodetector 946. FIG. 10 illustrates asimilar arrangement for a convex lens. The curvature of the lens (orlack thereof) can be selected to accommodate narrower or broader fieldsof view.

FIGS. 11A and 11B illustrate a more complex lens arrangement whereinlight being delivered for purposes of illumination goes through one ormore separate lenses from the lens used to collect incoming light ontothe photodetector 1146. Specifically, the lens can be a molded lensassembly having, for example, a central portion 1148 that is a convexlens (or other lens) for collecting light and focusing it on thephotodetector 1146, and one or more (e.g., 2, 3, 4, 5, 6)circumferentially arranged smaller lenses 1149 for distributing lightfrom the light bundle outwardly. Preferably, the optics are arranged tominimize internal reflections in the lens and reduce the mixing ofoutgoing and incoming light. If desired, the light source can includemicro-LEDs 1143 that are mounted underneath a suitable optic, or lens,1147, having optics matched to deliver light out of secondary lenses1149. If desired, the electronic photodetector chip and micro-LEDs canbe formed on the same chip or circuit board and have optics moldedthereover to simplify manufacture.

FIGS. 12A-12B illustrate an embodiment of an visualization stylet thathas a push-pull actuator for adjusting the axial distance between thelens and the photodetector. For example, a first portion of the actuator1210 is connected to the distal lens, and a second portion 1220 isattached to the central portion of the visualization stylet. The axiallength can be accomplished, for example, by a simple push pullarrangement. Or, if more precision is required, an actuator using ascrew thread can be used for a finer adjustment. Vent holds 1202 can beprovided to permit liquid or other fluid to flow into or out of thecavity space between the lens and the photodetector. It will beappreciated that such vent holes can be provided in any embodimentherein.

FIGS. 13A-13B illustrate a further embodiment of a visualization Veressneedle that incorporates flushing pathways or conduits into the sheathof the needle that surrounds the visualization stylet. As depicted,preferably 3, 4, or 6 longitudinal channels 1362 are provided (such assmall hypotubes) that are attached to the inner surface of the sheath(e.g., 220). These tubes 1362 act to evenly space the visualizationstylet from the outer sheath, and cooperate with the outer tube andvisualization stylet to define longitudinal passages 1368 for thepassage of insufflation gas, or simply to reduce friction. Asillustrated, the distal tip of tubes 1362 can be sealed, and laserdrilled holes can be formed that are transverse to the visualizationstylet, such that cleaning fluid directed through the tubes 1362 will bedirected transversely across the distal tip of the visualization styletto clean the lens 1348. Visualization stylet can be moved proximally anddistally with respect to the outer sheath when cleaning to facilitatecleaning during a cleaning process.

FIGS. 14A-14C illustrate an embodiment of a visualization Veress needlethat can be taken apart to facilitate different procedures. For example,14A illustrates a distal portion of a Veress needle, such as thatillustrated in FIGS. 2A-2C, having an visualization stylet 1406 that isconnected to an outer sheath 1402, wherein sheath 1402 is removablyconnected to a cannula 1404 that provides insufflation gas. Afterinsufflation, portion 1404 can be removed from portion 1402 (e.g., by ascrew threaded connection 1409), and a new proximal portion 1408 can beattached to threads 1409 to use the assembly as a laparoscope. Ifdesired, the visualization stylet 1406 can be removed from the assemblyof 1402 and 1404 (e.g., by detaching a screw threaded connection). Aseal (not shown) inside of component 1402 or 1404 can be provided toprevent the loss of insufflation gas.

FIGS. 15A-15C illustrate a system and method for separating thevisualization stylet 1506 from an outer cannula 1504, such as bydisconnecting a threaded connection. After the assembly is insertedunder visualization into the peritoneum, the visualization stylet can beremoved, if desired, leaving the outer sheath in place as a cannula. Or,the outer sheath can be removed, permitting an extension 1508 to beattached to visualization stylet 1506 to effectively use visualizationstylet 1506 as a laparoscope. If the visualization stylet is removed, aseal (not shown) can be provided within the body of the cannula 1504 toprevent undue loss of insufflation gas and to maintain pressure in theperitoneum. Visualization stylet can be removed, for example, to removethe lens cap (e.g, 148 et. seq.), permitting the visualization stylet tobe reintroduced without the lens cap. In a further embodiment of amethod, the lens is hinged to the end of the visualization stylet andcan swing out of the way by actuating an actuator.

FIGS. 16A-16C illustrate a further system and method for separating avisualization stylet from an outer cannula that is used to insufflatethe peritoneum. The outer cannula includes an insufflation port toreceive an insufflation gas input. After the assembly is inserted underdirect visualization into the peritoneum in FIG. 16A, the peritoneum canbe insufflated, and the visualization stylet can be removed as indicatedin FIG. 16B. The inner stylet can include a CMOS chip at its distal endas discussed elsewhere herein that can be covered by a removable distalcap or cover. The removable distal cap or cover can have a sharpened tipor a blunt dissection tip of any desired shape (e.g., conical,pyramidal, etc.) and any additional features that are desired (e.g.,ridges or wings or tabs extending outwardly from the removable tip). Thetip can thus be removed, and the inner stylet can be replaced into theouter cannula to perform an illumination and/or visualization function.Removal of the tip can be helpful as the tip can become obscured duringthe initial insertion process. If desired, a different tip can be addedto re-cover the CMOS chip, or the CMOS chip can have a lens that iscovered by the removable distal tip. The outer cannula can continue todirect carbon dioxide into the peritoneum.

In further accordance with the disclosure, FIGS. 17A-18N illustrate afurther embodiment of a visualization trocar assembly in accordance withthe present disclosure.

FIGS. 17A is an isometric view of an optical trocar assembly 1700 inaccordance with the present disclosure. FIG. 17B is a close up view of adistal end portion of device 1700. As depicted, device 1700 includes aproximal handle portion 1750 that may be removably coupled to a distalcannula 1710. Distal cannula 1710 includes a proximal handle portionthat is coupled to a distal shaft 1712. Shaft 1712 is hollow, has adistal end portion 1714, and is configured to receive an elongateremovable sheath 1720 therein. An annular gap can be defined between theinner surface of the lumen defined through the shaft 1712, and theexternal surface of the sheath 1720. A flushing assembly 1760 isprovided that includes an input port, a valve, and an output port thatdirects liquid or other beneficial agent to a cavity defined between thecannula 1710 and the handle 1750, resulting in fluid being directedbetween shaft 1712 and sheath 1720, or between shaft 1712 and opticalprobe 1780, discussed below, when the sheath 1720 is removed. Asillustrated, the sheath 1720 of embodiment 1700 can terminate in adissecting tip 1724 that can include one or more ridges or wings thatcan help bluntly dissect tissue that it is pressed against. If desired,the tip 1724 can be sharpened to the extent needed to help it traversetissue. As will be appreciated, while the shaft 1712 can be any desireddiameter, in the illustrated embodiment, the shaft has an outer nominaldiameter of about 2 mm.

FIGS. 17C-17E are views of a removable sheath of the device of FIG. 17A.As illustrated, sheath 1720 includes an elongate tubular member 1725,made, for example, from a metallic material as with shaft 1712. Sheath1720 includes a female luer lock, or other coupling, 1722 at a proximalend thereof, and includes distal tip 1724 coupled to a distal endthereof. In FIG. 17E, an alternative embodiment of a tip is shown havinga pair of opposing wing portions 1726. The tip is at least partiallytransparent, and can include one or more masked portions to render partof the tip opaque, such as by screen printing, as desired, to removeoptical artifacts resulting, for example, from wings 1726 or othergeometric feature.

FIGS. 18A-18K illustrate a process of removing the sheath 1720 from thedevice 1700. In use, Applicant has come to appreciate that opticaltrocars can easily become dirty or otherwise obscured during the initialprocess of directing the device into the body.

FIG. 18A is a view of the device 1700 prior to separating components toremove the sheath 1720 from the device. This may be done after thedevice 1700 has been inserted, for example, into the peritoneum of apatient. During insertion, the optical tip 1724 can be expected tobecome obscured. Thus, the proximal portion of the device may beremoved, the sheath can be removed from the proximal portion of thedevice, uncovering the optic or stylet, 1780, and the stylet can bereinserted into the cannula, permitting a clear view of what is insidethe patient.

FIG. 18B is a view of the device 1700 after rotating handle portion 1750of the device counter-clockwise with respect to a cannula portion of thedevice to release the “J” connector that connects the two components.With the “J” connector uncoupled, the handle bearing the sheath 1720 maybe withdrawn in a proximal direction as illustrated in FIG. 18C, and thecannula 1710 can be left in place in the patient. With the proximalportion of the assembly 1750 withdrawn, it is now possible to remove theprotective sheath 1720 from the optic/scope/stylet 1780. With referenceto FIGS. 18D-18G a sequence of steps is illustrated, including ofrotating the sheath proximal end connector 1722 with respect to thehandle portion of the device 1750 to decouple the luer lock of thesheath from the connector at the distal end of the handle portion 1750.The sheath in this embodiment is composed of the luer connector at theproximal end, and an elongate shaft 1725, that terminates in a distaltip that is optically clear. This sheath 1720, once removed, exposes theCMOS sensor at the distal end of the stylet 1780 as set forth in FIG.18G. FIG. 18H is a view showing relative placement of the cannula,sheath and handle after the sheath has been removed.

FIGS. 18I-18K illustrate reinserting the handle with the optical shaftinto the cannula after having removed the sheath. As can be seen, thestylet 1780 is reinserted into the cannula 1710, and the “J” connectoris reconnected. At this point, the overall assembly can be maneuveredabout to view different tissue structures.

FIG. 18 L is an isometric view of the handle of the device 1750 with theoptical probe or stylet 1780, FIG. 18M shows a close up view of a distalend 1784 of the optical probe and FIG. 18N illustrates a close up viewof a distal end portion of the handle 1750. As illustrated, the stylet1780 can include a CMOS chip disposed in the lumen of a tubular membermade, for example, from a stainless steel tube, such as a hypotube. Aproximal end of the stylet 1780 is coupled to the handle portion 1750 ofthe device and accordingly to conductors that send image signals to aprocessor (not shown). A close up view of the distal portion of thehandle portion 1750 in FIG. 18N illustrates a reduced diameter sectionthat is received by a bore in the cannula 1710. This reduced diametersection includes a seal, such as an o-ring, 1753 to fluidly seal thecannula 1710 to the handle portion 1750 when they are connected. A pin1752 on either side of the reduced diameter section is provided toengage the “J” connector. An insert 1751 can be seated in the housing ofthe handle 1750 that includes a female luer lock connector, for example.

If the exposed distal end of the stylet 1780 should become occluded inuse by tissue fragments or the like, the stylet may be partiallywithdrawn into the lumen of the tube 1712 of the cannula 1710, and theflushing assembly 1760 may be activated to direct pressurized liquid,such as saline, down the bore of the cannula. Withdrawing the styletinto the cannula 1710 forces it to be immersed in a pressurized streamof liquid, which has been found to be an effective technique forcleaning the CMOS chip at the distal end 1784 of the stylet 1780. Oncecleaned, the stylet can be reinserted into the bore to permit furthervisualization of the target site.

FIGS. 19A-19B illustrate full and partial isometric views of a springloaded insufflation needle assembly in accordance with the presentdisclosure. This embodiment is similar to the embodiment 1700, but addsthe feature of a spring loaded stylet 1980 and sheath 1920 residing in asharpened cannula 1910 (FIG. 19B), wherein the sharpened tip of thecannula 1910 cuts tissue, and the sheath 1920 containing the optic ispushed back into the handle 1950 against a spring force that pushes thesheath and stylet 1980 forward after the sharpened distal tip of thecannula 1910 has traversed tissue and has entered the peritoneum. Sheath1920 can have a connector 1922 at its proximal end that may function asa handle, and a distal end or tip 1924.

FIGS. 19C and 19D show cross sectional views of the device of FIG. 19Aalong a central axis of the device rotated 90 degrees with respect toeach other. As can be seen, the cannula 1910 is connected to the housingby “J” connector. A luer connector insert 1951, as will be appreciatedby those of skill in the art, is slidably received within a bore definedin a distal end of the housing and attached to stylet 1980. The luerconnector permits the stylet 1980 to traverse through it, and thehousing into a proximal cavity defined in the housing that in turnincludes a stopper or connector 1956 that is attached to the stylet1980. Proximal to the connector 1956 there resides a compression spring1990 that pushes on the connector 1956, which pushes the stylet 1980,and consequently the sheath 1920 and insert 1951 distally with respectto the cannula shaft 1912 and out of the distal end of the cannula shaftto protect tissue once the cannula breaches the abdominal cavity (orother cavity). As is evident from FIG. 19C, for example, the stylet 1980moves back and forth within the housing while attached to connector 1956and insert 1951 to limit the proximal-distal movement of thosecomponents with respect to the housing 1950. A heat sink 1992 isdisposed in the proximal cavity of the handle or housing 1950, wherein adistal end of the heat sink contacts the spring 1990, and a proximal endof the heat sink contacts a washer or spacer 1957. The annular spacer1957 is bounded by the heat sink 1992 at its distal face, and at a cap1996 at its proximal face. The proximal cavity of the handle issimilarly sealed by an o ring disposed between the cap 1996 and thehousing 1950. A connector 1998 is provided to connect to a power sourceand computer processor. Wires 1993 run from the connector to the LEDhoused in the heat sink 1992, wherein the LED shines light down fiberoptic strands or other light transmissive material inside of the tube ofthe stylet 1980 that shines distally around the periphery of the CMOSchip. The cannula 1910, as can be seen, includes an inner body 1913,that is situated within the bore of the cannula. The inner bodyfunctions as a guide tube that is illustrated as being funnel shaped anddefines a peripheral circumferential flange that seats against aperipheral circumferential shoulder defined in the cavity of outer body1917. An o-ring 1972 or other seal can be provided within an annulargroove formed into a distal reduced diameter section of housing 1950 toreceive outer body 1917, wherein an outer surface body 1917 can functionas a handle. The inner body 1913 and the outer body 1911 cooperate todefine an axial bore therethrough to hold the proximal end or region ofshaft 1912. Shaft can be attached to each of inner body 1913 and outerbody 1917. Inner body 1913, outer body 1917 and shaft 1912 cooperate todefine an annular cavity 1909 to receive flushing fluid by way of theflush port. The proximal end of shaft 1912 defines at least one fluidconduit 1911 therethrough to permit pressurized liquid from a syringe,for example, to be directed through the valve and the flushing system,into chamber 1909, through opening(s) 1911 and then down an annularlumen defined between the inner surface of the tubular shaft 1912 andthe outer surface of the stylet 1980 or the outer surface of the sheath1920, as appropriate.

FIGS. 19E-19H are views of an optical probe portion or stylet 1980 ofthe device of FIG. 19A. As can be seen, the stylet includes an elongatebody that terminates in a distal end by way of the CMOS chip. Electricalconductors traverse up the tubular body of stylet 1980 to the heat sink1992, where, from the cross section in FIG. 19H, it is apparent that anLED chip 1987 is mounted in a proximal bore of the heat sink 1992 thatis coupled to electrical conductors that connect to an externalconnector 1998 that carries power to the LED, and carries out signal viathe data cable. The LED element is centered on the axis of the deviceand directs light axially distally into the end of one or more fiberoptic elements that traverse the bore of the stylet 1980 and terminateadjacent to the CMOS chip to provide direct illumination of a work area.

FIG. 20A is a view of a further embodiment of an insufflation needleassembly 2000 in accordance with the present disclosure. As depicted,the assembly includes a removable cannula 2010 that includes a distallyextending tubular shaft 2012 through which a visualization stylet 2080(FIG. 20B) traverses to a distal end 2014 thereof. A flush port 2062 isprovided coupled to a valve 2064 can be used to flush the device 2000and the distal tip of the stylet 2080 as with the embodiments 1700,1900. Insufflation gas can be provided by way of port 2062 or otherport, as desired. A proximal handle section 2050 is removably coupled tothe cannula proximal portion, and includes a strain relief to provide agradual change in stiffness to electrical conductors 2077.

FIGS. 20B-20E show further aspects of the embodiment of FIG. 20A withthe cannula 2010 removed from the proximal portion of the device 2000.The cannula is removable from the proximal portion 2050 in the samemanner as the previous embodiments using a “J” type coupling, but itwill be appreciated that other types of connections can be used, such asan interference fit of various kinds, a keyed locking connection, andthe like. The distal end 2084 of the stylet 2080 includes a rounded end2085 and is attached, for example, but adhesive at location 2087 to thetube of the stylet 2080. The device 2000 can be configured as a smallvisualization trocar as with embodiment 1700, wherein the distal end ofthe cannula 2010 is not sharpened and the tip 2085 includes a dissectingtip that can be cleaned after insertion by withdrawing it proximallyinto cannula and clean fluid is flushed over it via valve 2064.

FIGS. 20E-20I show still further aspects of the embodiment of FIG. 20A.FIG. 20F presents a central cross section down the central axis of thedevice 2000, FIG. 20G presents an enlarged section of that crosssection, FIG. 20I presents a close up view of the distal end portion ofthe housing of the device, and FIG. 20H presents a rear isometric viewof device 2000 with the cannula 2010 removed. A compression spring 2090surrounds the stylet 2080, and is housed in a central axial bore thatids defined in both distal handle segment 2053 and proximal handlesegment 2057. A boss 2092, illustrated in the form of a tube surroundingthe stylet 2080, is adhered to the stylet 2080, and the compressionspring 2090 urges the boss distally by pushing it away from the proximalhousing segment 2057. This results in the stylet and its rounded distalend protruding from the sharpened distal end of the cannula 2010. Thestylet 2080 is coupled at its proximal end to a bushing 2094 that caninclude an LED element disposed therein that slides within acorresponding central axial bore defined along a proximal portion ofproximal housing segment 2057. Seals, such as o-ring seals, surround thedistal housing segment 2053 to form a fluid tight seal with an innercylindrical bore formed in the proximal end portion of the cannula 2010.Conductors that traverse the length of the stylet 2080 extend through aproximal end of the bushing 2094 and extend proximally through thestrain relief 2058 for coupling to a processor and/or electrical powersource.

FIGS. 20J-20L depict schematic views of aspects of the embodiment ofFIG. 20A. FIG. 20J illustrates a schematic side view of the cannulaassembly 2000 and FIG. 20K illustrates a side view of the visualizationstylet from its proximal connectors to its distal end and associatedbushing that attaches to the proximal end of the stylet shaft and thedistal ends of the conductor lines.

Thus, embodiments are disclosed that can be used as a miniaturevisualization trocar, or as a Veress-style needle with visualization.Nominally, the optical trocar or needle can have a 2.2 mm outerdiameter, for example, a removable outer cannula, and a refastenableconnector, such as a “J” type connector. The devices can include snap orinterference fits, and a removable visualization stylet to accomplishthe techniques set forth herein. Embodiments 1700, 1900, 2000 canutilize a “J” connector or other connector having two axial positions ofthe cannula with respect to the inner stylet or sheath as illustrated topermit the stylet to be withdrawn slightly to perform a flushing andcleaning operation by injecting fluid through the fluid port and downthe shaft of the cannula and around the distal tip of the visualizationstylet or sheath. The insufflation needles can be provided with anaudible and/or tactile indication of entry by making a “clicking” noiseafter the peritoneum has been breached so the surgeon knows to stoppushing the device.

In accordance with another embodiment, the Veress needle is inserted asset forth above under direct visualization. The outer cannula is removedby first disconnecting the inner stylet from an electrical connector sothe outer cannula can slide up over it. This leaves the inner cannula inplace. Then, a second, larger cannula (e.g., having a 5 mm or 10 mmdiameter passage, and optionally having an insufflation port) is slidover the inner visualization stylet to dilate the tissue radiallyoutwardly. The visualization stylet can be left in place, or it too canbe removed so that a further instrument can be introduced through thenewly placed cannula. For example, a larger scope with a larger lightsource and photodetector array can be inserted to provide improvedimaging. Advantageously, this permits entry into the peritoneum underdirect visualization using a small instrument, and permits insertion ofa much larger trocar without need for an obturator. This can be veryimportant, as there are many documented instances where surgeons haveattempted to insert an obturator with a larger trocar in the firstinstance, resulting in damaging internal structures such as bowels, orin severe cases, the abdominal aorta, resulting in death of the patient.As will be appreciated, trocars that are used and slid over the innerstylet preferably include outer ribs to prevent undesirable axial trocarmovement during the procedure.

While it is contemplated that the devices disclosed herein are generallyconfigured to access the peritoneum, it will be appreciated that thedisclosed embodiments can be used to access any desired portion of theanatomy, such as the abdominal cavity, the pelvic cavity, the thoraciccavity, sinus passages, and the like, as well as be connected to arobotic manipulator to permit the disclosed embodiments to be utilizedin robotic surgery. In further accordance with the disclosure,PCT/US2019/065723, filed Dec. 11, 2019 (which is incorporated byreference herein in its entirety) discusses a procedure includingintroducing a needle through the vagina and into the cul de sac todefine a passageway through which a visualization scope can pass. Thiscan support a diagnostic procedure, such as subsequently aspiratingfluid or obtaining a tissue sample, for example. A therapeutic procedurecan be performed such as delivering a beneficial agent to tissue in thecul de sac, among other things. The present disclosure further includesusing any suitable device as set forth herein, such as device 1700, tobe used in this procedure to enter through the posterior cul de sac viathe vagina under direct vision. The visualization stylet (e.g., 1720,1780) can then be withdrawn, and the visualization scope ofPCT/US2019/065723 can then be inserted into the cul de sac via cannula1710 and inspect the pelvic cavity in that manner. This can be done inconjunction with hysteroscopy, wherein the uterine cavity is filled withsaline. Given the pressure of the hysteroscope, there will be some fluidthat flushes through the fallopian tubes and into the peritoneal cavity.This fluid can then be aspirated by the scope device inPCT/US2019/065723 and the aspirated sample can then be sent topathology.

In accordance with further embodiments, the outer sleeves of theinsufflation needle disclosed herein can be blunted or dulled, andinstead a relatively sharper tip can be provided on the innervisualization stylet. In this instance, a minimal spring mechanism, orno spring mechanism can be used, and the tip of the visualizationstylet, while sharper, need not be extremely sharp because of its smalldiameter. These aspects can be applied to any embodiment of thisdisclosure.

It will be appreciated that one or more of the above-disclosed and otherfeatures and functions, or alternatives thereof, may be desirablycombined into many other different systems or applications. Variouspresently unforeseen or unanticipated alternatives, modifications,variations, or improvements therein may be subsequently made by thoseskilled in the art which are also intended to be encompassed by thepresent disclosure.

What is claimed is:
 1. A surgical instrument, comprising: a distal outerassembly including a distal housing having a hollow distally extendingneedle extending distally therefrom, the hollow distally extendingneedle having a distal end and a proximal end, wherein the distal outerassembly forms a passageway to pass at least one of fluid andinstruments therethrough; a visualization stylet assembly at leastpartially disposed within the passageway of the distal outer assembly,the visualization stylet assembly being removably coupled to the distalouter assembly, the visualization stylet assembly including: an elongatebody having a proximal end and a distal end; an electronic photodetectorchip mounted proximate the distal end of the elongate body, theelectronic photodetector chip having a distally facing surface to detectincoming light traveling along a proximal direction; a light source atleast partially integrated into the elongate body to project lightbeyond the electronic photodetector chip in a distal direction toprovide direct illumination to guide passage of the insufflation needleassembly; and a sleeve slidably disposed about at least a distal tipregion of the removable visualization stylet assembly, the sleeveincluding a lens element disposed at a distal end thereof to directlight through the lens element toward the electronic photodetector chip,wherein at least a portion of the sleeve extends proximally through thehollow distally extending needle and terminates in a location proximalto the proximal end of the hollow distally extending needle, and furtherwherein the distal outer assembly and the removable visualization styletassembly can be decoupled to permit removal of the sleeve after thehollow distally extending needle has been introduced into a patient. 2.The surgical instrument of claim 1, wherein the surgical instrument isan insufflation needle, and further wherein the removable visualizationstylet assembly includes a proximal housing portion defining a boretherein that includes a compression spring disposed therein, and furtherwherein the elongate body of the visualization stylet assembly is biasedin a distal direction with respect to the proximal housing portion bythe compression spring to cause the sleeve and elongate body to extendbeyond the distal end of the hollow distally extending needle.
 3. Thesurgical instrument of claim 1, wherein the visualization styletassembly further includes a connector body disposed concentrically abouta proximal region of the elongate body, the connector body including adistally facing connector to removably couple to the handle portion ofthe sleeve.
 4. The surgical instrument of claim 2, wherein thevisualization stylet assembly further includes a connector body disposedconcentrically about a proximal region of the elongate body, theconnector body including a distally facing connector to removably coupleto the handle portion of the sleeve, the connector body being receivedat least partially within the proximal housing of the surgicalinstrument.
 5. The surgical instrument of claim 4, wherein the handle ofthe sleeve includes a female locking member that is received by a malelocking member of the connector body to permit the sleeve to beselectively decoupled from the visualization stylet assembly to exposethe electronic photodetector chip.
 6. The surgical instrument of claim5, wherein the proximal housing defines a distally extending boss to besealingly received by the distal outer assembly, and further wherein thedistally extending boss is surrounded by a fluid tight seal to interfacewith an inwardly facing surface of the distal outer assembly.
 7. Thesurgical instrument of claim 6, wherein the distal outer assemblyfurther includes a guide tube disposed within the passageway of thedistal outer body to guide the visualization stylet assembly into thehollow distally extending needle.
 8. The surgical instrument of claim 7,wherein the visualization stylet assembly further includes a heat sinkat least partially disposed within the proximal housing to dissipateheat generated by the surgical instrument.
 9. The surgical instrument ofclaim 8, wherein the proximal housing defines a proximal cavity in whichthe elongate body of the visualization terminates at the proximal end ofthe elongate body, and further wherein at least one cable extends fromthe proximal end of the elongate body through the proximal cavity,through the heat sink, and to a connector located within a proximal capof the proximal housing.
 10. The surgical instrument of claim 8, whereinthe heat sink includes a proximal end, a distal end and defines a boreat least partially therethrough, and further wherein a LED chip ismounted at least partially within the bore of the heat sink, the LEDchip including a distally facing LED to direct light into thevisualization stylet to provide forward illumination.
 11. Aninsufflation needle assembly comprising: a distal assembly including ahollow distally extending needle having a sharpened distal end, aproximal end, and defining a needle bore therethrough, the hollowdistally extending needle being coupled at the proximal end thereof to adistal housing, the distal housing defining a proximal opening thereinleading to a cavity, the cavity being in fluid communication with theneedle bore; and a proximal assembly including: a proximal housing; acompression spring; and a visualization stylet having (i) an elongatebody defining a proximal end and a distal end, (ii) an electronicphotodetector chip mounted proximate the distal end of the elongatebody, the electronic photodetector chip having a distally facing surfaceto detect incoming light traveling along a proximal direction, (iii) alight source at least partially integrated into the elongate body toproject light beyond the electronic photodetector chip in a distaldirection to provide direct illumination to guide passage of theinsufflation needle assembly, and (iv) a boss in contact with a distalend of the compression spring to urge the visualization stylet in adistal direction; wherein the proximal assembly is configured to bereceived by the distal assembly and the proximal assembly is configuredto be removably coupled to the distal assembly, and the visualizationstylet is biased to extend beyond the distal end of the hollow distallyextending needle.
 13. The insufflation needle assembly of claim 12,wherein the proximal housing forms a handle of the device, the handlebeing defined by a distal handle segment that is received by the distalhousing, the distal handle segment including a peripheral seal tointerface with an inwardly facing surface of the distal housing.
 14. Theinsufflation needle assembly of claim 13, wherein the handle furtherincludes a proximal handle segment sealingly received by the distalhandle segment, wherein the proximal handle segment and distal handlesegment cooperate to define a spring bore to receive the compressionspring.
 15. The insufflation needle assembly of claim 14, wherein theboss of the visualization stylet is disposed within the spring bore at alocation distal relative to the compression spring, the compressionspring surrounds a length of the elongate body of the visualizationstylet located proximal to the boss, and further wherein the spring canbe removed from the handle by separating the proximal handle segmentfrom the distal handle segment and withdrawing the elongate member fromthe distal handle segment while the elongate body is coupled to theproximal handle segment.
 16. The insufflation needle assembly of claim15, wherein the proximal handle segment is coupled at a proximal endthereof to a strain relief assembly, the strain relief assembly defininga region of varying stiffness, wherein the strain relief assemblyterminates proximally in a plurality of connectors, the connectors beingcoupled to conductors that traverse the elongate body of thevisualization stylet.
 17. The insufflation needle assembly of claim 16,wherein the proximal handle segment defines a proximally facing bore,and the elongate body of the visualization stylet terminates at aproximal end within the bore and is attached to a bushing that issealingly received within the proximally facing bore of the proximalhandle segment.
 18. The insufflation needle assembly of claim 17,wherein the conductors traverse proximally from the connectors, throughthe strain relief assembly, through the proximal cavity of the proximalhandle segment, and into the elongate body of the visualization stylet.19. The insufflation needle assembly of claim 18, wherein the strainrelief includes a distally extending boss that is received within aproximal end of the proximally facing bore of the proximal handlesegment.
 20. The insufflation needle assembly of claim 13, wherein thedistal assembly can be coupled to the proximal assembly in at least twodiscrete axially distinct positions.